Archives: Agenda

• Understanding country-specific site application and approval requirements
• Reducing start-up timelines through effective planning and local partnerships
• Common challenges and pitfalls when activating sites across multiple regions
• Best practices for successful collaboration with investigators, sites, and regulators

• 了解各国特定的中心申请与审批要求。
• 通过有效规划和本地合作伙伴关系缩短启动时间。
• 跨多个区域启动中心时常见的挑战和陷阱。
• 与研究者、中心和监管方成功协作的最佳实践

• How to build a “Predict and Prevent” Supply Mindset
• Dynamic Re-supply Models for a Dynamic Clinical Reality
• A Step-by-Step Guide to Smoother Cross-Border Movements
• Rapid Response Protocols and Effective Contingency Planning
• Integrating Partners into a Single, Seamless Team

• 如何建立“预测并预防”的供应思维。
• 面向动态临床现实的动态补货模型。
• 更顺畅跨境运输的分步指南。
• 快速响应流程与有效的应急规划。
• 将合作伙伴整合为一个无缝协作团队。

Emsere专场

• Selecting the right countries and sites to support global development goals
• Using real-world data and feasibility insights to improve decision-making
• Aligning site selection with recruitment, operational, and regulatory strategies
• Creating scalable site networks for long-term global clinical development success

• 选择合适的国家和中心，以支持全球开发目标。
• 利用真实世界数据和可行性洞察改善决策。
• 将中心选择与招募、运营和法规策略相结合。
• 建立可扩展的中心网络，实现长期全球临床开发成功。

Ensuring end-to-end quality standards is arguably the most significant operational challenge for sponsors and CDMOs alike. This complexity is heightened by the reality that a clinical supply network is a potential point of failure, risking not only product quality but the integrity of the entire trial.
确保端到端质量标准，可以说是申办方和 CDMO 面临的最重要运营挑战。由于临床供应网络中的任何环节都可能成为故障点，这一复杂性被进一步放大，不仅会影响产品质量，也会影响整个试验的完整性。

• Rethinking the Role of the Quality Unit
• Risk-Based Supplier Qualification and Lifecycle Management
• Digital Platforms for End-to-End Quality Data Integrity
• Managing Change in a Distributed Network
• Building a Culture of Quality Across Organizational Boundaries

• 重新定义质量部门
• 基于风险的供应商资质认定与生命周期管理
• 用于端到端质量数据完整性的数字平台
• 分布式网络中的变更管理
• 跨组织边界建立质量文化

• Why Poland/CEE delivers: A proven early oncology environment — dense investigator networks, treatment-naive patients, and fast site activation built for FIH-to-Phase-II programs
• The regulatory pathway: What makes CEE data credible for FDA and EMA — and why country-level trial authorization in Europe is getting faster
• The case in practice: What early oncology development anchored in Poland/CEE looks like — and the operational set-up decisions that determine whether it delivers for your global filing

• 为什么波兰/中东欧可交付：成熟的早期肿瘤环境 – 密集的研究者网络、未接受治疗的患者群体，以及为 FIH 至 II 期项目打造的快速中心启动能力。
• 法规路径：是什么让中东欧数据获得 FDA 和 EMA 认可 – 以及为什么欧洲国家层面的临床试验授权正在加速。
• 实践案例：以波兰/中东欧为中心的早期肿瘤开发现状 – 哪些运营决策决定其能否服务全球申报。

• Predicting enrollment trends to ensure uninterrupted clinical trial supply
• Using data-driven forecasting to support agile decision-making
• Managing uncertainty across global, multi-site studies
• Best practices for responding to faster-than-expected recruitment and changing demand

• 预测入组趋势，确保临床试验供应不中断。
• 使用数据驱动的预测支持快速决策。
• 管理全球多中心研究中的不确定性。
• 应对超预期快速招募和需求变化的最佳实践。

Moderator: Daniel Gao, President, ISPE Supply Chain